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Session 10 Track 4: eCTD AdPromo Panel Discussion
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
The FDA AdPromo eCTD Guidance was finalized in June 2019 and becomes mandatory in June 2021. Although the guidance has been out for more than four years, many companies haven’t switched this process to eCTD. Commonly heard excuses are that it is complicated, expensive and just too hard to change a process that entails hundreds of submissions a year per marketed product. This session will be an informative and fun panel discussion with season experts who have made the switch to submitting AdPromo materials in eCTD format within their own companies… and lived to tell about it.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the process of submitting AdPromo materials in eCTD
- Anticipate the challenges to changing from a legacy process
- Gain perspective into all AdPromo stakeholders in and their perspectives on what’s important
Speaker(s)
Panelist
Thomas Noto
Lexicon Pharmaceuticals, United States
Senior Director, Regulatory Operations
Panelist
Heather Fisher, MS
Arivis, United States
Director, Regulatory Operations
Panelist
Rob Labriola, MS
Garuda Therapeutics, United States
Exec. Director, Regulatory Operations